Changes and implementation of the revised EN ISO 14971:2019 (Risk Management for Medical Devices)

EN ISO 14971 is an ISO standard for the application of risk management to medical devices and it was recently revised and released in December 2019.

This standard establishes the requirements for risk management for medical devices in determining the safety of a medical device by the medical device manufacturer during the product’s life cycle.

This standard is an important link to EN ISO 13485 and MDR, establishing a framework for risk analysis, assessment, evaluation, control, and review.

It requires the medical device manufacturer to plan risk management activities through the product’s life cycle.

It requires the to determine the individual and overall residual risk and benefit-risk ratio.

It also specifies a procedure for the review and monitoring of the device during production and post-production phases.